Childrens Tukol Multi-Symptom Cold and Flu

Description

Tukol® Children's Cold & Flu is a liquid formulation designed for pediatric use, specifically indicated for children aged 6 to 11 years. Each 4 fluid ounce (118 mL) bottle contains the following active ingredients: Acetaminophen (325 mg), Dextromethorphan HBr (10 mg), Guaifenesin (200 mg), and Phenylephrine HCl (5 mg). This product is formulated to relieve minor aches and pains, reduce fever, and alleviate nasal and chest congestion. It is distributed by Genomma Lab USA Inc., located in Houston, TX 77098.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, cough, minor aches and pains, sore throat, headache, and fever. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in children aged 6 years and older. The recommended dosage for children aged 6 to under 12 years is 2 teaspoons (10 mL) every 4 hours, not to exceed 5 doses within a 24-hour period. It is imperative that the dosing cup provided is used for accurate measurement.

Healthcare professionals should advise caregivers not to administer this product for more than 5 consecutive days unless directed by a physician. Additionally, it is crucial to adhere to the maximum dosage guidelines to avoid the risk of overdose. For children under 6 years of age, the use of this product is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In pediatric patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are used for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Prior to administration, it is essential to verify the patient's medication history with a healthcare professional.

• Exceeding the recommended dosage is contraindicated; refer to the overdose section for further details.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if it is used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance. Healthcare providers should remain vigilant for these potential adverse effects and educate caregivers on the importance of monitoring for signs of allergic reactions.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare professional is warranted. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Patients should be advised to discontinue use and consult a physician if they experience nervousness, dizziness, or sleeplessness. Additionally, if there is any redness or swelling, or if pain, nasal congestion, or cough worsens or persists beyond 5 days, medical advice should be sought. New symptoms or a fever that worsens or lasts more than 3 days also necessitate a consultation. Furthermore, if a cough recurs or is accompanied by a rash or headache that persists, it is crucial to seek medical attention, as these may be indicative of a serious condition.

Regular monitoring and appropriate laboratory tests may be necessary to ensure the safe use of this product, particularly in patients with pre-existing liver conditions or those taking multiple medications.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can be categorized by seriousness and frequency.

Severe adverse reactions include the risk of liver damage associated with acetaminophen. Patients may experience severe liver damage if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use this product concurrently with other medications containing acetaminophen. In the event of an overdose, which may occur if the recommended dose is exceeded, immediate medical attention is critical, even if no symptoms are initially apparent. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any skin reaction occur, patients must discontinue use and seek medical assistance promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should stop using the product and consult a healthcare provider if they experience these symptoms, or if they notice redness or swelling. Furthermore, if pain, nasal congestion, or cough worsens or persists beyond five days, or if new symptoms arise, medical advice should be sought. A fever that worsens or lasts more than three days, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected, may indicate a serious condition requiring evaluation.

Patients should also consult a doctor before using this product if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or persistent or chronic cough, such as that associated with asthma. Additionally, those experiencing a cough with excessive phlegm should seek medical advice prior to use. It is also recommended that patients inform their healthcare provider or pharmacist if they are taking the blood-thinning medication warfarin, as this may influence the safety and efficacy of the product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

In pediatric patients, this medication should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it is advised to avoid use for a period of 2 weeks following the discontinuation of an MAOI to prevent adverse interactions.

For children who are prescribed the anticoagulant warfarin, it is recommended to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Tukol Multi-Symptom Cold and Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 2 teaspoons (10 mL) every 4 hours, with a maximum of 5 doses in a 24-hour period. The duration of use should not exceed 5 days unless directed by a healthcare professional.

Caution is advised due to the potential for severe liver damage if more than 5 doses are taken within 24 hours. Prior to administration, it is important to consult a doctor if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as that associated with asthma), or cough accompanied by excessive phlegm. Additionally, consultation with a doctor or pharmacist is recommended if the child is concurrently taking the anticoagulant warfarin.

Geriatric Use

The prescribing information for Children's Tukol Multi-Symptom Cold and Flu does not provide specific data regarding the use of this medication in geriatric patients. The insert primarily addresses pediatric use and lacks any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions pertinent to elderly patients.

Healthcare providers should exercise caution when considering the use of this medication in geriatric patients due to the absence of relevant clinical findings or guidance. It is advisable to monitor elderly patients closely for any potential adverse effects or interactions, given the lack of established safety and efficacy data in this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned, underscoring the importance of seeking medical advice prior to use. Healthcare professionals are advised to carefully consider the potential risks and benefits when discussing this product with women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Additionally, patients must be cautioned against the concurrent use of this product with other medications containing acetaminophen, as this combination may further increase the likelihood of severe liver damage. Regular assessment of liver function is recommended for patients with compromised liver function to ensure safety and efficacy while using this product.

Overdosage

Taking more than the recommended dose of the medication may lead to liver damage. It is essential for healthcare professionals to recognize the seriousness of an overdose and the potential for significant health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose. Early intervention can be pivotal in preventing severe complications associated with liver damage.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to manage any symptoms that may arise as a result of the overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

There have been reports of severe skin reactions associated with acetaminophen, including symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be cautioned against using this medication for children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of an MAOI. If there is any uncertainty regarding the use of MAOIs, patients should be directed to seek guidance from a healthcare professional.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to seek medical attention if they notice any redness or swelling, or if pain, nasal congestion, or cough worsens or persists for more than five days. New symptoms that arise should also prompt a consultation with a healthcare provider.

If a patient’s fever worsens or lasts more than three days, or if a cough recurs or is accompanied by a rash or persistent headache, they should be advised to stop use and contact a doctor, as these may indicate a serious condition.

When using this product, patients must not exceed the recommended dosage, and they should be made aware of the potential risks of overdose. It is essential for healthcare providers to ask patients about any pre-existing conditions before use, including liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or persistent or chronic cough, such as that associated with asthma. Patients should also be advised to consult a doctor if they have a cough that produces excessive phlegm.

Finally, patients taking the blood-thinning medication warfarin should be encouraged to seek advice from a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a carton that contains essential Drug facts. It should be stored at a temperature range of 15-30°C (59-86°F). Refrigeration is not recommended, and the carton should be retained for reference to the complete Drug facts.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Tukol Multi-Symptom Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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